Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Overview
- Phase
- Phase 2
- Intervention
- Clonidine 1 mcg/Kg
- Conditions
- Postoperative Pain
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 80
- Primary Endpoint
- Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
Detailed Description
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.
Investigators
Renato Santiago Gomez
PhD
Federal University of Minas Gerais
Eligibility Criteria
Inclusion Criteria
- •CHildren 1 - 10 years old.
- •ASA I E II ( American Society of Anesthesiology)
- •hypospadias surgery
Exclusion Criteria
- •parents refuse
- •Infection
- •Coagulation disorders
- •Allergy to anesthetics
- •Abnormalities of the sacral spine
Arms & Interventions
Clonidine 1 mcg/Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
Intervention: Clonidine 1 mcg/Kg
Clonidine 2 mcg/ Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
Intervention: Clonidine 2 mcg/ Kg
Clonidine 3 mcg/Kg
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
Intervention: Clonidine 3 mcg/ Kg
Outcomes
Primary Outcomes
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
Time Frame: 24 hours after the surgery